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Ulcerative ColitisPhase 2NCT03869905

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

A Phase 2 study testing Aquamin® in people with Ulcerative Colitis, run by Muhammad N Aslam, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Aquamin®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
8 Aug 2019to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) OR having a mild disease.
  • A negative pregnancy test

Who cannot join

  • No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.
  • Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission

The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.

Being tested
Aquamin®, Placebo first then Aquamin®
Keywords
Remission
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aquamin®Drug

    Also called Nutritional

    4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)

  • Placebo first then Aquamin®Drug

    Also called Maltodextrin

    4 capsules per day; 2 to be taken in the morning and 2 in the evening

Study groups in NCT03869905
Study groupRoleWhat they receive
Aquamin®ExperimentalTo be taken for 180 days
Receives: Drug: Aquamin®
Placebo first then Aquamin®Placebo comparatorPlacebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)
Receives: Drug: Aquamin®; Drug: Placebo first then Aquamin®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score

    This is a self-administered questionnaire. There are 32 quality of life questions related to bowel function. Each response corresponds to a letter 'a' through 'g'. Whereas 'a' indicates high frequency and 'g' indicates minimal frequency. The total IBDQ score ranges between 32 and 224, with higher scores indicating better quality of life.

    Measured: Up to day 180

  2. Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring

    UCDAI/Mayo Scoring consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.

    Measured: Up to day 180

  3. Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA)

    Interleukin 8 levels are measured in picograms per milliliter (pg/mL)

    Measured: Up to day 180

  4. Change in serum C-reactive protein (CRP) levels as measured in a blood sample.

    Serum C-reactive protein ([CRP levels)] will be reported in milligram per deciliter (mg/dL)

    Measured: Up to day 180

  5. Change in fecal calprotectin levels measured in a stool sample

    Fecal calprotectin will be reported in microgram per gram (µg/g)

    Measured: Up to day 180

Secondary outcomes (1)

  1. Changes in serum liver function tests

    Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment

    Measured: Up to day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start8 Aug 2019
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This pilot study includes individuals with mild ulcerative colitis / ulcerative colitis in remission, and is a randomized, double-blind, placebo-controlled trial with two parallel treatment groups for the first 90 days. Subjects on placebo will be crossed over to Aquamin® after the halfway visit at day 90. Subjects on Aquamin® will continue their treatment until the end.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03869905
Sponsor's protocol ID
HUM00156676
Status last verified
Aug 2026
First submitted
8 Mar 2019
Last updated
25 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aslam MN, McClintock SD, Attili D, Pandya S, Rehman H, Nadeem DM, Jawad-Makki MAH, Rizvi AH, Berner MM, Dame MK, Turgeon DK, Varani J. Ulcerative Colitis-Derived Colonoid Culture: A Multi-Mineral-Approach to Improve Barrier Protein Expression. Front Cell Dev Biol. 2020 Nov 23;8:577221. doi: 10.3389/fcell.2020.577221. eCollection 2020.

    PubMed 33330453

  • Attili D, McClintock SD, Rizvi AH, Pandya S, Rehman H, Nadeem DM, Richter A, Thomas D, Dame MK, Turgeon DK, Varani J, Aslam MN. Calcium-induced differentiation in normal human colonoid cultures: Cell-cell / cell-matrix adhesion, barrier formation and tissue integrity. PLoS One. 2019 Apr 17;14(4):e0215122. doi: 10.1371/journal.pone.0215122. eCollection 2019.

    PubMed 30995271

  • McClintock SD, Attili D, Dame MK, Richter A, Silvestri SS, Berner MM, Bohm MS, Karpoff K, McCarthy CL, Spence JR, Varani J, Aslam MN. Differentiation of human colon tissue in culture: Effects of calcium on trans-epithelial electrical resistance and tissue cohesive properties. PLoS One. 2020 Mar 5;15(3):e0222058. doi: 10.1371/journal.pone.0222058. eCollection 2020.

    PubMed 32134920

  • Aslam MN, Bassis CM, Bergin IL, Knuver K, Zick SM, Sen A, Turgeon DK, Varani J. A Calcium-Rich Multimineral Intervention to Modulate Colonic Microbial Communities and Metabolomic Profiles in Humans: Results from a 90-Day Trial. Cancer Prev Res (Phila). 2020 Jan;13(1):101-116. doi: 10.1158/1940-6207.CAPR-19-0325. Epub 2019 Nov 26.

    PubMed 31771942

  • Aslam MN, McClintock SD, Jawad-Makki MAH, Knuver K, Ahmad HM, Basrur V, Bergin IL, Zick SM, Sen A, Turgeon DK, Varani J. A Multi-Mineral Intervention to Modulate Colonic Mucosal Protein Profile: Results from a 90-Day Trial in Human Subjects. Nutrients. 2021 Mar 14;13(3):939. doi: 10.3390/nu13030939.

    PubMed 33799486

  • Varani J, McClintock SD, Aslam MN. Organoid culture to study epithelial cell differentiation and barrier formation in the colon: bridging the gap between monolayer cell culture and human subject research. In Vitro Cell Dev Biol Anim. 2021 Feb;57(2):174-190. doi: 10.1007/s11626-020-00534-6. Epub 2021 Jan 5.

    PubMed 33403624

  • Varani J, McClintock SD, Aslam MN. Cell-Matrix Interactions Contribute to Barrier Function in Human Colon Organoids. Front Med (Lausanne). 2022 Mar 10;9:838975. doi: 10.3389/fmed.2022.838975. eCollection 2022.

    PubMed 35360746

  • Aslam MN, Turgeon DK, McClintock S, Allen R, Sen A, Varani J. A multi-mineral intervention is associated with improved intestinal permeability in patients with ulcerative colitis: results from a pilot trial. Front Med (Lausanne). 2026 Jun 22;13:1805900. doi: 10.3389/fmed.2026.1805900. eCollection 2026.

    PubMed 42440705

  • Aslam MN, McClintock SD, Moraga G, Nadeem DM, Harber I, Varani J. Proteomic profile of human colon organoids: effects of a multi-mineral intervention alone and in the presence of pro-inflammatory and anti-inflammatory treatments. Front Gastroenterol (Lausanne). 2025 Jul 2;4:1592669. doi: 10.3389/fgstr.2025.1592669. eCollection 2025.

    PubMed 41822286

  • Aslam MN, Heffernan SM, Varani J. Editorial: The role of minerals and trace elements in chronic diseases. Front Cell Dev Biol. 2023 Nov 21;11:1333011. doi: 10.3389/fcell.2023.1333011. eCollection 2023. No abstract available.

    PubMed 38078008

  • Varani J, McClintock SD, Nadeem DM, Harber I, Zeidan D, Aslam MN. A multi-mineral intervention to counter pro-inflammatory activity and to improve the barrier in human colon organoids. Front Cell Dev Biol. 2023 Jul 5;11:1132905. doi: 10.3389/fcell.2023.1132905. eCollection 2023.

    PubMed 37476158

  • Aslam MN, Turgeon DK, Appelman HD, Stidham R, McClintock S, Allen R, Moraga G, Harber I, Jencks KJ, McNeely MM, Sen A, Jepsen KJ, Varani J. A multi-mineral intervention to improve disease-related and mechanistic biomarkers in ulcerative colitis patients: Results from a randomized trial. PLoS One. 2025 Dec 8;20(12):e0337408. doi: 10.1371/journal.pone.0337408. eCollection 2025.

    PubMed 41359652

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aquamin® in people with Ulcerative Colitis, run by Muhammad N Aslam, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score (time frame: Up to day 180). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03869905, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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